Physicians find that writing the prescription isn't always enough
■ A column that answers questions on ethical issues in medical practice
The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA. Posted Dec. 4, 2006.
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Few, if any, brand-name prescription medications are cheap. And for patients who need but cannot afford them, the quest for "free drugs" is fraught with frustrations.
Physicians who want to help their patients find affordable or free prescription medications face ethical and professional challenges in doing so. Doctors have three options for securing brand-name medications for their patients who cannot afford them:
Patient-assistance programs. Also known as indigent drug programs or charitable drug programs, these can be publicly or privately funded. Pharmaceutical companies usually operate these private programs that provide specific medications at low or no cost to patients who qualify. Eligibility is based on an income means test that often requires patients to be at or below the federal poverty level.
Free samples. Pharmaceutical representatives routinely give clinics and physician offices samples of prescription medications.
Less-expensive alternatives. If a generic substitute for the brand-name medication is available, some patients may be able to pay out of pocket for the medication.
Each option has its obstacles
Patient-assistance programs are designed and operated by most large pharmaceutical companies for specific drugs they manufacture and decide to offer at discounts, and the application process and eligibility criteria vary tremendously among companies. Some programs, for example, require patients to renew their applications for assistance every three months; others have shorter or longer time frames.
Other variations in qualifying criteria include whether verification of a patient's Social Security number is required and whether information about insurance status, including Medicare Part D, is included. These differences in eligibility criteria can frustrate the most well-intentioned physicians as they try to provide good care and supportive services to their patients.
Free drug samples are generally packaged in small amounts, which makes it cumbersome for physicians to dispense a full month's supply to a patient. Samples do not usually come with the Food and Drug Administration-approved package inserts that explain the safety risks, dosage and indications for use.
All drugs, prescription or over the counter, must be stored properly and checked for expiration dates. In many ways, the clinic or doctor's office that dispenses free samples is serving as a pharmacy, and its physicians must recognize the responsibilities associated with that function.
A less-expensive medication alternative is an appealing option, not only to patients and their physicians, but to the health care system as a whole. But this option is not necessarily hassle free for physicians either.
It is not always apparent whether a less-expensive, bioequivalent substitute for a brand-name medication is available. Chantix is the latest anti-smoking cessation agent to hit the market. Is the nicotine patch a generic substitute for Chantix? It certainly wouldn't be for the patient who has already tried the patch and been unable to give up smoking.
In the best of cases, it takes time and effort, and perhaps patient trials, to identify a less-expensive, yet effective medication that the patient can afford to purchase out of pocket.
Programs like the one recently rolled out by the nation's largest pharmacy chain, Wal-Mart, may increase the availability and affordability of generics. The superstore has introduced a program that allows consumers to receive a 30-day supply from among 331 generic drugs for $4 per prescription.
Striving to reduce hassles
Given these options, how can a physician minimize hassles and limit disruption to the workflow of a busy medical practice while still helping patients get needed medications ? Fortunately, there are efforts to streamline the application process for patient-assistance programs. For example, the pharmaceutical companies have come together to establish a Web site (link) to help physicians and patients identify and apply for drug-assistance programs offered by various companies.
While the Web site streamlines the application paperwork, differences in eligibility criteria and reapplication times remain unaddressed. Patients are still at risk of falling through the "reapplication crack," and being without medication until their free drugs are refilled.
Some cynics allege that drug companies resist uniformity in these eligibility criteria and renewal periods because standardization would make it easy for physicians to compare value across companies, and no company wants to be hit up for free assistance more often than its competitors.
Some physician practices have been able to hire patient advocates to help patients navigate through the paperwork and identify the appropriate drug companies. When physician offices are unable to bring on another staff member, it is not unusual for a community member to volunteer several hours per week to help with the process.
If patients on drug-assistance programs are without medications for a time, physicians can tide them over with free drug samples. But there are no easy ways to get around the drug packaging, safety, storage and expiration issues. Pharmaceutical companies are not going to provide free medications in bulk to physician offices, in part because they are not pharmacies either.
The only way I have found to address many of these practical hassles in my clinical practice is to ask for help from the staff. Often the job responsibilities of a nurse, office manager or insurance/Medicaid assistant includes helping patients apply for drug-discount programs and ensuring that drug samples are still viable.
For solo or small group practices, there may be neither sufficient office staff nor community volunteers to help patients apply for drug assistance, and in these cases patients have to assume greater responsibility.
It is frustrating to physicians who understand their ethical obligations to help vulnerable patients, yet face external challenges they cannot manage well in the context of a busy medical practice.
Ultimately, the solution to this ethical dilemma will have to come in the form of policy that redresses the larger problem of insufficient health insurance coverage for all of our patients.
Audiey Kao, MD, PhD, vice president of ethics, American Medical Association; internist who volunteers at a free clinic in Chicago
The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA.